Study in Parkinson Disease of Exercise (SPARX): Translating high-intensity exercise from animals to humans

Contemporary Clinical Trials

Volumn 36, Issue 1, 2013, Pages 90-98

  Moore, Charity G ^a   Schenkman, Margaret ^b   Kohrt, Wendy M ^b   Delitto, Anthony ^c   Hall, Deborah A ^d   Corcos, Daniel ^e  

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF PITTSBURGH   (United States)

^d RUSH UNIVERSITY MEDICAL CENTER   (United States)

^e UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

Author keywords

Exercise; Futility; Parkinson disease; Phase II; Randomized controlled trial; Unified Parkinson Disease Rating Scale

Indexed keywords

ARTICLE; BECK DEPRESSION INVENTORY; CONTROLLED STUDY; EPWORTH SLEEPINESS SCALE; EXERCISE; FEASIBILITY STUDY; FEMALE; FOLLOW UP; HEART RATE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL HISTORY; MEDICATION COMPLIANCE; MULTICENTER STUDY; PARKINSON DISEASE; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; UNIFIED PARKINSON DISEASE RATING SCALE;

EXERCISE; FUTILITY; PARKINSON DISEASE; PHASE II; RANDOMIZED CONTROLLED TRIAL; UNIFIED PARKINSON DISEASE RATING SCALE;

ANIMALS; DISEASE MODELS, ANIMAL; EXERCISE; HEALTH STATUS; HUMANS; MENTAL HEALTH; PARKINSON DISEASE; RESEARCH DESIGN; SEVERITY OF ILLNESS INDEX; SINGLE-BLIND METHOD; SOCIOECONOMIC FACTORS; WALKING;

EID: 84880282982     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2013.06.002     Document Type: Article

References (69)

1. Ahlskog J.E. Does vigorous exercise have a neuroprotective effect in Parkinson disease?. Neurology 2011, 77(3):288-294.
2. Miyai I., Fujimoto Y., Ueda Y., Yamamoto H., Nozaki S., Saito T., et al. Treadmill training with body weight support: its effect on Parkinson's disease. Arch Phys Med Rehabil 2000, 81(7):849-852.
3. Fisher B.E., Wu A.D., Salem G.J., Song J., Lin C.H., Yip J., et al. The effect of exercise training in improving motor performance and corticomotor excitability in people with early Parkinson's disease. Arch Phys Med Rehabil 2008, 89(7):1221-1229.
4. Schenkman M., Hall D., Kumar R., Kohrt W.M. Endurance exercise training to improve economy of movement of people with Parkinson disease: three case reports. Phys Ther 2008, 88(1):63-76.
5. Ridgel A.L., Vitek J.L., Alberts J.L. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabil Neural Repair 2009, 23(6):600-608.
6. Burini D., Farabollini B., Iacucci S., Rimatori C., Riccardi G., Capecci M., et al. A randomised controlled cross-over trial of aerobic training versus Qigong in advanced Parkinson's disease. Eura Medicophys 2006, 42(3):231-238.
7. Herman T., Giladi N., Gruendlinger L., Hausdorff J.M. Six weeks of intensive treadmill training improves gait and quality of life in patients with Parkinson's disease: a pilot study. Arch Phys Med Rehabil 2007, 88(9):1154-1158.
8. Shulman L.M., Katzel L.I., Ivey F.M., Sorkin J.D., Favors K., Anderson K.E., et al. Randomized clinical trial of 3 types of physical exercise for patients with Parkinson disease. Arch Neurol 2012, 1-8.
9. Schenkman M., Hall D.A., Baron A.E., Schwartz R.S., Mettler P., Kohrt W.M. Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Phys Ther 2012, 92(11):1395-1410.
10. Miyai I., Fujimoto Y., Yamamoto H., Ueda Y., Saito T., Nozaki S., et al. Long-term effect of body weight-supported treadmill training in Parkinson's disease: a randomized controlled trial. Arch Phys Med Rehabil 2002, 83(10):1370-1373.
11. Toole T., Maitland C.G., Warren E., Hubmann M.F., Panton L. The effects of loading and unloading treadmill walking on balance, gait, fall risk, and daily function in parkinsonism. NeuroRehabilitation 2005, 20(4):307-322.
12. Corcos D., Robichaud J.A., David F., Leurgans S., Vaillancourt D., Poon C., et al. A two year randomized controlled trial of progressive resistance exercise for Parkinson's disease. Mov Disord 2013, [Epub ahead of print]. 10.1002/mds.25380.
13. Gerecke K.M., Jiao Y., Pani A., Pagala V., Smeyne R.J. Exercise protects against MPTP-induced neurotoxicity in mice. Brain Res 2010, 1341:72-83.
14. Petzinger G.M., Fisher B.E., Van Leeuwen J.E., Vukovic M., Akopian G., Meshul C.K., et al. Enhancing neuroplasticity in the basal ganglia: the role of exercise in Parkinson's disease. Mov Disord 2010, 25(Suppl. 1):S141-S145.
15. Zigmond M.J., Cameron J.L., Leak R.K., Mirnics K., Russell V.A., Smeyne R.J., et al. Triggering endogenous neuroprotective processes through exercise in models of dopamine deficiency. Parkinsonism Relat Disord 2009, 15(Suppl. 3):S42-S45.
16. Goodwin V.A., Richards S.H., Taylor R.S., Taylor A.H., Campbell J.L. The effectiveness of exercise interventions for people with Parkinson's disease: a systematic review and meta-analysis. Mov Disord 2008, 23(5):631-640.
17. Zigmond M.J., Cameron J.L., Hoffer B.J., Smeyne R.J. Neurorestoration by physical exercise: moving forward. Parkinsonism Relat Disord 2012, 18(Suppl. 1):S147-S150.
18. Tomlinson C.L., Patel S., Meek C., Herd C.P., Clarke C.E., Stowe R., et al. Physiotherapy intervention in Parkinson's disease: systematic review and meta-analysis. BMJ 2012, 345:e5004.
19. The NINDS NET-PD Investigators A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease. Neurology 2006, 66(5):664-671.
20. The NINDS NET-PD Investigators A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease. Neurology 2007, 68(1):20-28.
21. Schwid S.R., Cutter G.R. Futility studies: spending a little to save a lot. Neurology 2006, 66(5):626-627.
22. Elm J.J., Goetz C.G., Ravina B., Shannon K., Wooten G.F., Tanner C.M., et al. A responsive outcome for Parkinson's disease neuroprotection futility studies. Ann Neurol 2005, 57(2):197-203.
23. Tilley B.C., Palesch Y.Y., Kieburtz K., Ravina B., Huang P., Elm J.J., et al. Optimizing the ongoing search for new treatments for Parkinson disease: using futility designs. Neurology 2006, 66(5):628-633.
24. Hughes A.J., Ben-Shlomo Y., Daniel S.E., Lees A.J. What features improve the accuracy of clinical diagnosis in Parkinson's disease: a clinicopathologic study. Neurology 1992, 42(6):1142-1146.
25. Hughes A.J., Daniel S.E., Kilford L., Lees A.J. Accuracy of clinical diagnosis of idiopathic Parkinson's disease: a clinico-pathological study of 100 cases. J Neurol Neurosurg Psychiatry 1992, 55(3):181-184.
26. Hughes A.J., Ben-Shlomo Y., Daniel S.E., Lees A.J. What features improve the accuracy of clinical diagnosis in Parkinson's disease: a clinicopathologic study. Neurology 2001, 57(10 Suppl. 3):S34-S38.
27. Goetz C.G., Wuu J., McDermott M.P., Adler C.H., Fahn S., Freed C.R., et al. Placebo response in Parkinson's disease: comparisons among 11 trials covering medical and surgical interventions. Mov Disord 2008, 23(5):690-699.
28. Levin B. The utility of futility. Stroke 2005, 36(11):2331-2332.
29. Fahn S., Elton R.L., U.D.Committee Unified Parkinson's Disease Rating Scale, in recent developments in Parkinson's disease 1987, 153-163. Macmillan Healthcare Information, Florham Park, NJ. S. Fahn (Ed.).
30. Hoehn M.M., Yahr M.D. Parkinsonism: onset, progression and mortality. Neurology 1967, 17(5):427-442.
31. Goetz C.G., Poewe W., Rascol O., Sampaio C., Stebbins G.T., Counsell C., et al. Movement Disorder Society Task Force report on the Hoehn and Yahr staging scale: status and recommendations. Mov Disord 2004, 19(9):1020-1028.
32. Chou K.L., Amick M.M., Brandt J., Camicioli R., Frei K., Gitelman D., et al. A recommended scale for cognitive screening in clinical trials of Parkinson's disease. Mov Disord 2010, 25(15):2501-2507.
33. Beck A.T., Ward C.H., Mendelson M., Mock J., Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry 1961, 4:561-571.
34. Jenkinson C., Fitzpatrick R., Peto V., Harris R., Saunders P. New user manual for the PDQ-39, PDQ-8 and PDQ index 2008, Health Services Research Unit, University of Oxford, Oxford.
35. Kazis L.E., Selim A., Rogers W., Ren X.S., Lee A., Miller D.R. Dissemination of methods and results from the veterans health study: final comments and implications for future monitoring strategies within and outside the veterans healthcare system. J Ambul Care Manage 2006, 29(4):310-319.
36. Kazis L.E., Miller D.R., Skinner K.M., Lee A., Ren X.S., Clark J.A., et al. Applications of methodologies of the Veterans Health Study in the VA healthcare system: conclusions and summary. J Ambul Care Manage 2006, 29(2):182-188.
37. Trenkwalder C., Kohnen R., Hogl B., Metta V., Sixel-Doring F., Frauscher B., et al. Parkinson's disease sleep scale-validation of the revised version PDSS-2. Mov Disord 2011, 26(4):644-652.
38. Johns M.W. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 1991, 14(6):540-545.
39. Ritvo P.G., Fischer J.S., Miller D.M., Andrews H., Paty D., LaRocca N.G. Multiple sclerosis quality of life inventory: a user's manual 1997, National Multiple Sclerosis Society, New York, NY.
40. Goetz C.G., Tilley B.C., Shaftman S.R., Stebbins G.T., Fahan S., Martinez-Martin P., et al. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord 2008, 23(15):2129-2170.
41. Kirwan J.P., Bourey R.E., Kohrt W.M., Staten M.A., Holloszy J.O. Effects of treadmill exercise to exhaustion on the insulin response to hyperglycemia in untrained men. J Appl Physiol 1991, 70(1):246-250.
42. Christiansen C.L., Schenkman M.L., McFann K., Wolfe P., Kohrt W.M. Walking economy in people with Parkinson's disease. Mov Disord 2009, 24(10):1481-1487.
43. Cianci H. Parkinson's disease: fitness counts 2004, National Parkinson Foundation. 2 ed.
44. Kang U.J., Auinger P. Activity enhances dopaminergic long-duration response in Parkinson disease. Neurology 2012, 78(15):1146-1149.
45. Fahn S., Oakes D., Shoulson I., Kieburtz K., Rudolph A., Lang A., et al. Levodopa and the progression of Parkinson's disease. N Engl J Med 2004, 351(24):2498-2508.
46. CTCAE Common terminology criteria for adverse events version 4.0 2010, National Cancer Institute.
47. Kohrt W.M., Malley M.T., Coggan A.R., Spina R.J., Ogawa T., Ehsani A.A., et al. Effects of gender, age, and fitness level on response of VO2 max to training in 60-71yr olds. J Appl Physiol 1991, 71(5):2004-2011.
48. Jankovic J., McDermott M., Carter J., Gauthier S., Goetz C., Golbe L., et al. Variable expression of Parkinson's disease: a base-line analysis of the DATATOP cohort. The Parkinson Study Group. Neurology 1990, 40(10):1529-1534.
49. Poewe W.H., Wenning G.K. The natural history of Parkinson's disease. Neurology 1996, 47(6 Suppl. 3):S146-S152.
50. Palesch Y.Y., Tilley B.C., Sackett D.L., Johnston K.C., Woolson R. Applying a phase II futility study design to therapeutic stroke trials. Stroke 2005, 36(11):2410-2414.
51. Korczyn A.D., Brooks D.J., Brunt E.R., Poewe W.H., Rascol O., Stocchi F. Ropinirole versus bromocriptine in the treatment of early Parkinson's disease: a 6-month interim report of a 3-year study. 053 Study Group. Mov Disord 1998, 13(1):46-51.
52. Rascol O., Brooks D.J., Brunt E.R., Korczyn A.D., Poewe W.H., Stocchi F. Ropinirole in the treatment of early Parkinson's disease: a 6-month interim report of a 5-year levodopa-controlled study. 056 Study Group. Mov Disord 1998, 13(1):39-45.
53. Schrag A., Sampaio C., Counsell N., Poewe W. Minimal clinically important change on the unified Parkinson's disease rating scale. Mov Disord 2006, 21(8):1200-1207.
54. Jankovic J., Watts R.L., Martin W., Boroojerdi B. Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease. Arch Neurol 2007, 64(5):676-682.
55. Rascol O., Dubois B., Caldas A.C., Senn S., Del Signore S., Lees A. Early piribedil monotherapy of Parkinson's disease: a planned seven-month report of the REGAIN study. Mov Disord 2006, 21(12):2110-2115.
56. Trenkwalder C., Kies B., Rudzinska M., Fine J., Nikl J., Honczarenko K., et al. Rotigotine effects on early morning motor function and sleep in Parkinson's disease: a double-blind, randomized, placebo-controlled study (RECOVER). Mov Disord 2011, 26(1):90-99.
57. Ravina B., Palesch Y. The phase II futility clinical trial design. Prog Neurother Neuropsychopharmacol 2007, 2(1):27-38.
58. Dobkin B.H. Progressive staging of pilot studies to improve phase III trials for motor interventions. Neurorehabil Neural Repair 2009, 23(3):197-206.
59. Sutoo D., Akiyama K. Regulation of brain function by exercise. Neurobiol Dis 2003, 13(1):1-14.
60. Rhyu I.J., Bytheway J.A., Kohler S.J., Lange H., Lee K.J., Boklewski J., et al. Effects of aerobic exercise training on cognitive function and cortical vascularity in monkeys. Neuroscience 2010, 167(4):1239-1248.
61. Vucckovic M.G., Li Q., Fisher B., Nacca A., Leahy R.M., Walsh J.P., et al. Exercise elevates dopamine D2 receptor in a mouse model of Parkinson's disease: in vivo imaging with [(1)F]fallypride. Mov Disord 2010, 25(16):2777-2784.
62. Robichaud J.A., Corcos D.M. Motor deficits, exercise and Parkinson's disease. Quest 2005, 57:85-107.
63. Zigmond M., Smeyne R.J. Foreword: exercise and the brain. Brain Res 2010, 1341:1-2.
64. Physical Activity Guidelines Advisory Committee Physical Activity Guidelines Advisory Committee report 2008, [Washington, DC]. U.S.D.o.H.a.H. Services (Ed.).
65. Kleim J.A., Jones T.A. Principles of experience-dependent neural plasticity: implications for rehabilitation after brain damage. J Speech Lang Hear Res 2008, 51(1):S225-S239.
66. Tillerson J.L., Caudle W.M., Reveron M.E., Miller G.W. Exercise induces behavioral recovery and attenuates neurochemical deficits in rodent models of Parkinson's disease. Neuroscience 2003, 119(3):899-911.
67. Tillerson J.L., Cohen A.D., Philhower J., Miller G.W., Zigmond M.J., Schallert T. Forced limb-use effects on the behavioral and neurochemical effects of 6-hydroxydopamine. J Neurosci 2001, 21(12):4427-4435.
68. Fisher B.E., Petzinger G.M., Nixon K., Hogg E., Bremmer S., Meshul C.K., et al. Exercise-induced behavioral recovery and neuroplasticity in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-lesioned mouse basal ganglia. J Neurosci Res 2004, 77(3):378-390.
69. Cameron J.L., Rockcastle N., Zigmond M.J., Leak R.K., Smith A., Lopresti B.J., et al. Exercise protects the striatum against MPTP damage in nonhuman primates in Society for Neuroscience 2009, [Chicago, IL].